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Researchers Push FDA To Raise Standards For Metal-On-Metal Hips

Flaws in the 510(k) process prevented FDA from noticing high metal-on-metal revision rates, researchers write in the New England Journal of Medicine. Their argument is based on a predicate “ancestry” analysis of DePuy’s recalled ASR hip system.

Researchers pressed FDA to start requiring PMAs for metal-on-metal hips in a Jan. 10 piece in the New England Journal of Medicine.

Metal-on-metal hips have been the subject of substantial international scrutiny in recent years since global registries have shown that patients receiving the devices require revision surgery much more frequently than...

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